Quality of Health Economic Studies (QHES) - Tool or Mask?

In this issue of the Journal, Grissinger, Globus, and Fricker, from the Institute of Safe Medication Practices (ISMP), focus on the patient-practitioner interaction as a primary opportunity to reduce medication errors. This is also the principal focus of a campaign launched by the U.S. Food and Drug Administration (FDA) in August 2002 that had the theme: “Think through the risks and benefits of medicines.” This consumer-oriented education campaign urged patients to ask questions of their physicians and pharmacists and to become more active in the process of assessing the benefits and risk of prescription drugs: “before using any medicine—as with many things that you do every day—you should think through the benefits and the risks in order to make the best choice for you.” Managed care pharmacy can effectively use the same metaphor: when driving a car, you wear your seat belt; when taking medications, you talk to your pharmacist and physician. Managed care pharmacy can also have a measurable effect on the medication errors and ADEs through reliance on the principles of continuous quality improvement, a fundamental, core area of the Academy of Managed Care Pharmacy’s “Pharmacy’s Framework for Drug Therapy Management in the 21st Century.” The framework’s self-assessment tool contains specific tasks and components within key functional areas that permit individual, organization, and system analysis of opportunities for quality improvement in drug therapy management. Key functional areas in patient safety and reduction of medication errors and ADEs are interspersed throughout the framework, with emphasis on patient-practitioner interaction in interpersonal communication (area 1.1), patient education (1.3, 4.4, 5.3, and 6.3), patient and worker safety (1.4), drug selection (3.2), coordination of care (3.5), etc. Many of the solutions necessary to prevent and reduce medical errors and medication errors will involve changes in processes and systems that “make it easy to do it right.”

improvement in drug therapy management. Key functional areas in patient safety and reduction of medication errors and ADEs are interspersed throughout the framework, with emphasis on patient-practitioner interaction in interpersonal communication (area 1.1), patient education (1. 3, 4.4, 5.3, and 6.3), patient and worker safety (1.4), drug selection (3.2), coordination of care (3.5), etc. 43 Many of the solutions necessary to prevent and reduce medical errors and medication errors will involve changes in processes and systems that "make it easy to do it right." 44 ■■ Quality of Health Economic Studies (QHES)-Tool or Mask? Managed care pharmacists face a mountain of data when making decisions about the relative value of alternate drug therapies in individual patients and in the selection of preferred agents in prescription drug formularies. The objective is to apply rules of evidence-based medicine to derive the information that will be important to develop and refine clinical practice guidelines (CPGs) and clinical practice models (CPMs) that will make it possible to achieve effective disease management. This paradigm might be made more clear by thinking of this continuum in terms of structure, process, and outcome in which the "structure" derives from evidence-based medicine, the "process" from application of CPGs and CPMs, and the outcome as successful attainment of disease management.
The U.S. National Library of Medicine reported an average 10,000 new lines (articles) referenced in MEDLINE each week at year-end 2001. 45 The amount of data and information in the medical literature is growing further and is now quite easily overwhelming, setting aside the additional data and information disseminated in the lay press and on the Internet. It is now more important than ever to find tools to help filter and interpret enormous amounts of data and thousands of medical literature references. The Quality of Health Economics (QHES) instrument may be such a tool. On the other hand, this tool, as any tool, can be misapplied. In addition to possible inherent flaws in the instrument, some of which will only be discovered upon repeated use and scrutiny of the results, users of the QHES have the potential to distort the findings of the studies that they are measuring.
Ofman, Sullivan, Neumann, et al. in this issue of the Journal, take the bold step of introducing a new instrument, the QHES. 46 The true value of this instrument and method will not be determined immediately, and readers have reason to be critical. Shaya and Lyles in an accompanying editorial suggest that managed care pharmacy should evaluate critically this new instrument and method. 47 Motheral argues for caution and even rejection of the instrument and method. 48 Science advances through scholarly debate. By articulating and applying the QHES, Ofman et al. permit others to critique the instrument and method and to propose changes that will enhance value by increasing its validity, reliability, and usefulness. We are certainly in need of better tools to evaluate published data.
The QHES has value, perhaps not so much for its final numeric "score," but in its qualitative analysis of the results of assessment of individual items in the 16-item instrument. Some researchers will no doubt want to change the weight of individual items to improve the utility of the QHES in application to particular uses. The architects of the QHES will need to explain for other researchers that the 3 compound items (numbers 5, 8 and 11) in the QHES require affirmation of both questions. Item number 5, "Was uncertainty handled by: 1) statistical analysis to address random events; 2) sensitivity analysis to cover a range of assumptions?" could have one "yes" and one "no" answer, yet the weight for the item is "9." Item number 8 asks 2 questions and has a weight of "7": "Did the analytic horizon allow time for all relevant and important outcomes?" "Were benefits and costs that went beyond 1 year discounted (3% to 5%) and justification given for the discount rate?" Item no. 11 also has 2 questions, with one score of "7": "Were the health outcome measures/scales valid and reliable? If previously tested valid and reliable measures were not available, was justification given for the measures/scales used?" At the least, the QHES instrument and method present us with a useful platform for scholarly debate on attempts to bring more science to pharmacoeconomics, a relatively young discipline still in search of credibility in the scientific community.

■■ Antihypertensive Drug Effects on Renal Function and Myocardial Infarction and Implications of the ALLHAT Study Results
In managed care we must study the effects of drugs outside the